Understanding how diagnostics influence antimicrobial decision-making is key to successful clinical trial design.

Timothy M Rawson, Luke S P Moore

Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases(2023)

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Because the landscape of near-patient, rapid, infection-related diagnostics continues to evolve, a paucity of large, well-designed clinical trials is available. Most studies within this field remain observational in nature. Fartoukh [ [1] Fartoukh M. Respiratory multiplex PCR and procalcitonin to reduce antibiotic exposure in severe SARS-CoV-2 pneumonia: a multicenter randomised controlled trial. Clin Microbiol Infect. 2023; 29 (S1198-743X(23)00031-9): 734-743https://doi.org/10.1016/j.cmi.2023.01.009 Abstract Full Text Full Text PDF Scopus (1) Google Scholar ] attempt to redress this, reporting a multicentre randomized controlled trial of the impact of a respiratory multiplex PCR (mPCR) plus procalcitonin (PCT) strategy against standard of care (culture and antigen-based diagnostics plus PCT) in patients with confirmed SARS-CoV-2 in 13 French intensive care units [ [1] Fartoukh M. Respiratory multiplex PCR and procalcitonin to reduce antibiotic exposure in severe SARS-CoV-2 pneumonia: a multicenter randomised controlled trial. Clin Microbiol Infect. 2023; 29 (S1198-743X(23)00031-9): 734-743https://doi.org/10.1016/j.cmi.2023.01.009 Abstract Full Text Full Text PDF Scopus (1) Google Scholar ]. The study enrolled 194 patients early in the COVID-19 pandemic. Although the intervention diagnostic identified greater numbers of bacterially coinfected patients (48.4%) compared with the control group (21.4%), enabling clinicians to have a more accurate picture of potentially pathogenic organisms causing infection, the trial failed to demonstrate any difference in its primary outcome; the number of antibiotic-free days at day 28 after randomization (12 [0–24] intervention vs. 14 [0–24] control; p 0.89, difference −2.0 [95% CI −10.6 to 6.6]) [ [1] Fartoukh M. Respiratory multiplex PCR and procalcitonin to reduce antibiotic exposure in severe SARS-CoV-2 pneumonia: a multicenter randomised controlled trial. Clin Microbiol Infect. 2023; 29 (S1198-743X(23)00031-9): 734-743https://doi.org/10.1016/j.cmi.2023.01.009 Abstract Full Text Full Text PDF Scopus (1) Google Scholar ]. Respiratory multiplex PCR and procalcitonin to reduce antibiotic exposure in severe SARS-CoV-2 pneumonia: a multicentre randomized controlled trialClinical Microbiology and InfectionVol. 29Issue 6PreviewWe aimed at assessing the efficacy and safety on antibiotic exposure of a strategy combining a respiratory multiplex PCR (mPCR) with enlarged panel and daily procalcitonin (PCT) measurements, as compared with a conventional strategy, in adult patients who were critically ill with laboratory-confirmed SARS-CoV-2 pneumonia. Full-Text PDF Open Access
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